Contract Quality Systems Manager

1 day ago


Exton, Pennsylvania, United States Hired by Matrix Full time
Job Title: Contract Quality Systems Manager

We are seeking a highly skilled Contract Quality Systems Manager to join our team at Hired by Matrix, Inc. This is a contract position that offers a competitive salary, benefits, and a 401k option with a company match after one year.

Job Summary:

The Contract Quality Systems Manager will be responsible for maintaining and improving Quality Systems for the Americas Region to ensure ongoing compliance with applicable compendia, GMPs, and regulatory guidance. This includes quality risk management, documentation, global and local auditing, health authority inspection management, training, event management, and change control.

Key Responsibilities:
  • Collaborate with Quality System personnel on other sites to ensure compliance with GMP and Data Integrity requirements.
  • Develop and manage processes to ensure site compliance with global quality policies, regulatory requirements, and industry standards.
  • Support external and internal audits for the Americas sites.
  • Trend quality metrics for the Americas sites and contribute to the oversight of Quality Systems core responsibilities.
  • Develop and manage processes to ensure site compliance with global quality policies, regulatory requirements, and industry standards.
Requirements:
  • Bachelor's degree in a science-related discipline (preferred).
  • 5-7 years of experience working with Quality Systems, including deviation, change control, CAPA, audit, and training.
  • Demonstrated proficiency in working with Quality Systems IT applications.
  • Training within a regulated pharmaceutical/biotech/medical device environment.
  • Understanding and application of CGMPs (EU, JP, US).
  • Detailed knowledge and application of electronic Quality Systems (i.e., TrackWise, Documentum).
  • Strong attention to detail and excellent written and verbal communication skills.
  • Computer proficiency in MS Word and Excel, Project, and Visio.
  • Demonstrates process orientation and strong project management skills.
  • Ability to anticipate potential problems and take proactive action to avoid/minimize impact.
What We Offer:

Hired by Matrix, Inc. is an Equal Opportunity Employer and proud to be certified as both a Woman-Owned Business Enterprise and a Woman-Owned Small Business. We offer competitive salaries, benefits after 60 days, and a 401k option with a company match after one year.

Connect with us on LinkedIn today and learn more about how HbM can change your career: https://www.linkedin.com/company/hired-by-matrix-inc/

Check out our Career Center: https://www.hiredbymatrix.com/find-work/open-positions/



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